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Occlusal Stabilization Splints and Sleep Disordered Breathing

Primary Purpose

Sleep Bruxism

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Maxillary OSS

Mandibular OSS

Modified farrar splint

About this trial

This is an interventional treatment trial for Sleep Bruxism

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

diagnosed with sleep bruxism
prescribed an occlusal splint

Exclusion Criteria:

Less than 18 years old
Secondary obstructive sleep apnea diagnosis
Genetic disease that contributes to possible secondary obstructive sleep apnea
Patient refuses to sign informed consent document
Patient does not speak or read English
More than two missing posterior teeth (excluding third molars)
Presence of gross malocclusion

Sites / Locations

The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Maxillary OSS

Mandibular OSS

Modified farrar splint

Arm Description

Outcomes

Primary Outcome Measures

Change in peripheral capillary oxygen saturation (SpO2) as measured by the MediByte device

Change in pulse as measured by the MediByte device

Change in airflow as measured by the MediByte device

Change in chest plethysmography as measured by the MediByte device

Change in abdomen plethysmography as measured by the MediByte device

Change in masticatory muscle activity as measured by the MediByte device

Secondary Outcome Measures

Change in airway anatomy as measured by CBCT

Full Information

NCT ID

NCT04078074

First Posted

September 1, 2019

Last Updated

October 1, 2021

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT04078074

Brief Title

Occlusal Stabilization Splints and Sleep Disordered Breathing

Official Title

Occlusal Stabilization Splints and Sleep Disordered Breathing

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2022 (Anticipated)

Primary Completion Date

July 1, 2023 (Anticipated)

Study Completion Date

July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to investigate the effects of mandibular occlusal stabilization splint (OSS) and modified farrar splint on sleep bruxism and respiratory indices and the effects of occlusal splints on the airway volume through imaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Bruxism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Maxillary OSS

Arm Type

Experimental

Arm Title

Mandibular OSS

Arm Type

Experimental

Arm Title

Modified farrar splint

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Maxillary OSS

Intervention Description

Maxillary OSS will be a night guard for the top teeth. Digital impressions will be taken at the first appointment. After delivery appointment the patient will take home a sleep test monitor and bruxism monitor to record respiration and muscle activity during sleep.This will be a 2 night sleep study (Night A will be without splint and Night B will be with splint). Therefore, the patient will sleep with the mouth guard one night and the monitoring device two nights. Subjects will also undergo cone beam computed tomography (CBCT) airway imaging with and without splint.

Intervention Type

Device

Intervention Name(s)

Mandibular OSS

Intervention Description

Mandibular OSS will be a night guard for the bottom teeth.Digital impressions will be taken at the first appointment. After delivery appointment the patient will take home a sleep test monitor and bruxism monitor to record respiration and muscle activity during sleep.This will be a 2 night sleep study (Night A will be without splint and Night B will be with splint). Therefore, the patient will sleep with the mouth guard one night and the monitoring device two nights. Subjects will also undergo CBCT airway imaging with and without splint.

Intervention Type

Device

Intervention Name(s)

Modified farrar splint

Intervention Description

Modified farrar splint will be a night guard for the top teeth that positions and maintains the lower jaw in a more forward position.Digital impressions will be taken at the first appointment. After delivery appointment the patient will take home a sleep test monitor and bruxism monitor to record respiration and muscle activity during sleep. This will be a 2 night sleep study (Night A will be without splint and Night B will be with splint). Therefore, the patient will sleep with the mouth guard one night and the monitoring device two nights. Subjects will also undergo CBCT airway imaging with and without splint.

Primary Outcome Measure Information:

Title

Change in peripheral capillary oxygen saturation (SpO2) as measured by the MediByte device

Time Frame